NATIONAL HEALTH TECHNOLOGY

SYSTEM (SINATS) IN PORTUGAL:

4-YEAR LANDMARK ANALYSIS

Ferreira C1§, Vandewalle B1, Félix J1

1. Exigo Consultores, Lisboa, Portugal; § cesar.ferreira@exigoconsultores.com

INTRODUCTION / OBJECTIVES RESULTS (cont.)

In force since June 2015, the National Health Technology System (SiNATS) has triggered the
creation of pharmacotherapeutic assessment guidelines (November 2016), and, in 2018,
the review of the economic assessment guidelines, whose conclusion is expected during
2019. This 4-year landmark analysis provides a deep insight into all assessments and
appraisals before the publication of the new economic assessment guidelines.
The majority of the decisions comprised antineoplastic and immunomodulating agents,
technologies for cardiovascular system and anti-infectives for systemic use. Substantial
differences between the outcome of decision are still observed across the different
therapeutic areas – Figure 3.
Figure 3 Therapeutic area (ATC) distribution per decision outcome and negative share within the same ATC

METHODS 43%, (n=37) antineoplastic and immunomodulating agents 68.8%, (n=11) 23%

17.4%, (n=15) cardiovascular system 0%, (n=0) 0%

All Health Technology Assessment (HTA) reports published by INFARMED up to June 2019 0%, (n=0) 0%
12.8%, (n=11) antiinfectives for systemic use
were reviewed. Variables collected: type of health technology, health care setting (hospital
9.3%, (n=8) respiratory system 0%, (n=0) 0%
or ambulatory), therapeutic value assessment and degree, economic value assessment,
12.5%, (n=2) 29%
type of economic analysis and decision outcome. 5.8%, (n=5) blood and blood forming organs

4.7%, (n=4) nervous system 6.3%, (n=1) 20%

The analysis sample included assessments of drugs with initial marketing authorisation or
2.3%, (n=2) various 0%, (n=0) 0%
variation date after June 2015 and assessments of any other technology made under
0%, (n=0) 0%
SiNATS. Multiple assessments with different regulatory dates within the same report were 2.3%, (n=2) alimentary tract and metabolism

considered as individual observations. Therapeutic area was defined according to the first 1.2%, (n=1) musculo-skeletal system 0%, (n=0) 0%

level of Anatomical Therapeutic Chemical Classification (ATC) System. 1.2%, (n=1) sensory organs 0%, (n=0) 0%

0%, (n=0) Systemic hormonal preparations 6.3%, (n=1) 100%

RESULTS 0%, (n=0) genito urinary system and sex hormones 6.3%, (n=1) 100%

50% 40% 30% 20% 10% 0% ATC classification 0% 10% 20% 30% 40% 50% 60% 70% Neg | ATC
The 4-year cut-off determined a 2-fold increase in the sample size compared to the year Positive Negative
before [1]. The final sample was composed of 102 assessments/appraisals made fully Neg | ATC: proportion of negative decisions within the total decisions of each therapeutic indication

under SiNATS. Only one assessment was related to medical devices (Figure 1). Added therapeutic value was recognised in 48.0% of the assessments, followed by
equivalence (37.3%) and absence of value (14.7%). Compared with the latest cut-off, the
Figure 1 Data base algorithm and definition of analysis sample
degree of added therapeutic value is being described more often (65.3% versus 58.3%).
Cut-off Jun-2018 Jun-2019
HTA assessment
However, non-quantifiable degree represents up to 24.5% of the latter.
n=388 reports collected and n=455
fully read
Figure 4 Degree of therapeutic value amongst added therapeutic value decision and cut-off variations
Δ -14.3% Δ -34.7% Δ -2.0% Δ 46.9% Δ 95.9%
Excluded (n=24) Excluded (n=24)
• Generic (n= 18) • Generic (n= 18) 14.3% 8.2%
• Biossimilar (n = 1) • Biossimilar (n = 1) Explicit 65.3% Major
Considerable
• Regulatory ineligibility ( n=1) • Regulatory ineligibility ( n=1) 12.2% 6.1%
Δ 12.0% (n =32) Moderate
• Renegotiation (n=1) • Renegotiation (n=1)
Minor
• Report issues (n = 3) • Report issues (n = 3) 24.5%
o Not available (n=1) o Not available (n=1)
o Duplicate (n=2) o Duplicate (n=2) Not mentioned Non-quantifiable
34.7%
Δ -16.7% (n=17)
Total HTA
assessment
n=364 n=431
reports included Globally, cost-minimization or price comparisons represented the majority of the economic
analysis (56.3%), as cost-effectiveness and/or cost-utility analysis only accounted for 41.4%
Added (n=28)
Added (n=18) • Therapeutic indication (n = 17)
of the total. The distribution of the type of economic analysis per therapeutic conclusion is
• Therapeutic indication (n = 11) • Dosage (n =9) presented on Figure 5.
• Dosage (n =6) • Pharmaceutical form (n=1)
• Pharmaceutical form (n=1) • Two products (n=2) Figure 5 Type of economic analysis by therapeutic conclusion per cut-off date
4.2%, (n=1) 4.1%, (n=2)
4.2%, (n=1) 2%, (n=1) CEA
n=382 Final data base n=459 18.4%, (n=7)
26.1%, (n=6) CUA
16.7%, (n=4) 20.4%, (n=10)
CEA and CUA
n=51 SiNATS analysis sample n=102
CMA
20.8%, (n=5) Price comparison
Overall, 84.3% (86 out of 102) of the funding decisions were positive (Figure 2). Negative 28.6%, (n=14) Others
funding decisions occurred mostly during the therapeutic assessment (93.8%; 15 out of 16).
12.5%, (n=3)
Amongst the latter, negative funding decisions were more frequent (86.5%; 13 out of 15) CEA: cost-effectiveness
12.2%, (n=6) 81.6%, (n=31) analysis
within the hospital setting, when compared to the ambulatory (13.3%; 2 out of 15). 73.9%, (n=17) CUA: cost-utility
analysis
Figure 2 Breakdown of the decisions made under SiNATS per cut-off date CMA: cost-minimization
41.7%, (n=10) analysis
32.7%, (n=16) Other: budget cap or
not applicable
(Truvada)

Jun-2018 Jun-2019 Jun-2018 Jun-2019

75.0 % Added Equivalence
June 80.0 % June 86.7%
90.2% 9.8 % 84.3% 15.7 % 93.8% Type of therapeutic conclusion
2018 25.0 % 2019
20.0 %
100.0 %
CONCLUSION
6.3% 13.3% The vast majority of decisions resulted in the public financing of
100.0%
medicines, however, negative decisions have been rising, mainly driven by
Positive Therapeutic Hospital the therapeutic assessment, which is also ultimately influencing the type
Negative Economic Ambulatory
of economic analysis.
References: [1] Félix, A.R., et al., Three years of National Health Technology Assessment System (SiNATS) in Portugal, in ISPOR 2018. 2018: Barcelona; [2] INFARMED. Infomed - Base de dados de medicamentos. [cited 2019 June]; Available from: http://app7.infarmed.pt/infomed/; [3] INFARMED.
Relatórios de avaliação. [cited 2019 June]; Available from: http://www.infarmed.pt/web/infarmed/relatorios-de-avaliacao; [4] European Medicines Agency. Medicines. [cited 2019 June]; Available from: https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when.

ISPOR Europe 2019 | 2-6 November 2019 | Copenhagen, Denmark PNS210